Press Release: Dupixent® demonstrates potential to become first
biologic to treat COPD by showing significant reduction in
exacerbations in pivotal trial
Dupixent® demonstrates potential to become first
biologic to treat COPD by showing significant reduction in
exacerbations in pivotal trial
- First and only biologic to demonstrate
clinically meaningful and statistically significant reduction (30%)
in exacerbations compared to placebo
- First and only biologic to show rapid
and significant improvement in lung function (160 mL in FEV1)
compared to placebo (77 mL in FEV1)
- First and only biologic to demonstrate
significant improvements in quality of life and respiratory
symptoms
- COPD is the third leading cause of
death worldwide with no new treatment approaches approved in more
than a decade; trial enrolled patients with moderate to severe
disease and evidence of type 2 inflammation (i.e., blood
eosinophils ≥300 cells/μL)
- COPD is the seventh disease in which
Dupixent has shown positive pivotal results, confirming the key
role of IL-4 and IL-13 in these type 2 inflammatory diseases
Paris and Tarrytown, N.Y.
March 23, 2023. The primary and
all key secondary endpoints were met in a Phase 3 trial evaluating
the investigational use of Dupixent® (dupilumab) compared to
placebo in adults currently on maximal standard-of-care inhaled
therapy (triple therapy) with uncontrolled chronic obstructive
pulmonary disease (COPD) and evidence of type 2 inflammation.
Dupixent is the first and only biologic to demonstrate a clinically
meaningful and highly significant reduction (30%) in moderate or
severe acute exacerbations of COPD (rapid and acute worsening of
respiratory symptoms), while also demonstrating significant
improvements in lung function, quality of life and COPD respiratory
symptoms.
Dietmar Berger, M.D., Ph.D.Head of
Global R&D ad interim and Chief Medical Officer at Sanofi
"Change cannot come quick enough for people living with
uncontrolled COPD but, unfortunately, many investigational
treatments have failed to demonstrate significant clinical outcomes
leaving these vulnerable patients with limited treatment options.
We took a bold approach with our direct to Phase 3 program, shaving
years off standard clinical development timelines. We are excited
to share these unprecedented and potentially paradigm-shifting
clinical results, which may give new hope to patients, caregivers
and physicians.”
COPD is a life-threatening respiratory disease that
damages the lungs and causes progressive lung function decline.
Symptoms include persistent cough and breathlessness that may not
only impair the ability to perform routine daily activities, but
can also lead to anxiety, depression and sleep disturbances. COPD
is also associated with a significant health and economic burden
due to recurrent acute exacerbations that require systemic
corticosteroid treatment and/or lead to hospitalization or even
death. Smoking is a key risk factor for COPD, but even individuals
who quit smoking can still develop the disease. In the U.S. alone,
approximately 300,000 people live with uncontrolled COPD with type
2 inflammation.
George D.
Yancopoulos, M.D., Ph.D.President
and Chief Scientific Officer at Regeneron“COPD is an urgent global
health concern and a notoriously difficult-to-treat disease due to
its heterogeneity, with no novel treatments approved in more than a
decade. In this landmark Phase 3 trial, patients with uncontrolled
COPD achieved clinical outcomes with Dupixent at a magnitude never
before seen with a biologic. These results also validate the role
type 2 inflammation plays in driving COPD in these patients,
advancing the scientific community’s understanding of the
underlying biology of this disease. We look forward to discussing
these exciting results with regulatory authorities.”
In the BOREAS Phase 3 trial (the first of two Phase
3 trials), 939 adults who were current or former smokers aged 40 to
80 years were randomized to receive Dupixent (n=468) or placebo
(n=471), added to maximal standard-of-care inhaled therapy.
Patients receiving Dupixent experienced:
- 30% reduction in moderate or severe
acute COPD exacerbations over 52 weeks (p=0.0005), the primary
endpoint.
- Improved lung function from baseline
by 160 mL at 12 weeks compared to 77 mL for placebo (p<0.0001),
with the benefit versus placebo sustained through week 52
(p=0.0003), both of which were key secondary endpoints.
Dupixent met all endpoints tested in the hierarchy,
including improvement in patient-reported health-related quality of
life as measured by St. George’s Respiratory Questionaire (SGRQ)
and reduction in the severity of respiratory symptoms of COPD as
measured by Evaluation Respiratory Symptoms: COPD (E-RS: COPD)
Scale.
The safety results were generally consistent with
the known safety profile of Dupixent in its approved indications.
Overall rates of adverse events (AE) were 77% for Dupixent and 76%
for placebo. AEs more commonly observed with Dupixent compared to
placebo included headache (8.1% Dupixent, 6.8% placebo), diarrhea
(5.3% Dupixent, 3.6% placebo) and back pain (5.1% Dupixent, 3.4%
placebo). AEs more commonly observed with placebo compared to
Dupixent included upper respiratory tract infection (9.8% placebo,
7.9% Dupixent), hypertension (6.0% placebo, 3.6% Dupixent) and
COVID-19 (5.7% placebo, 4.1% Dupixent). AEs leading to deaths were
balanced between the two arms (1.7% placebo, 1.5% Dupixent).
Detailed efficacy and safety results from this
trial will be presented in a future scientific forum.
The broader Sanofi and Regeneron COPD clinical
research program includes Phase 3 trials with itepekimab, a fully
human monoclonal antibody that binds to and inhibits interleukin-33
(IL-33). Itepekimab received Fast Track Designation from the U.S.
Food and Drug Administration in January 2023 for the treatment of
COPD in patients who do not currently smoke. Data from this pivotal
program is expected in 2025.
The safety and efficacy of Dupixent and itepekimab
in COPD have not been fully evaluated by any regulatory
authority.
About the Dupixent COPD
Phase 3 Trial ProgramBOREAS is
one of two pivotal trials in the Dupixent COPD program. The
randomized, Phase 3, double-blind, placebo-controlled trial
evaluated the efficacy and safety of Dupixent in 939 adults who
were current or former smokers aged 40 to 80 years with
moderate-to-severe COPD. All patients in the trial had evidence of
type 2 inflammation, as measured by blood eosinophils ≥300
cells/µL. During the 52-week treatment period, patients received
Dupixent or placebo every two weeks, added to triple therapy of
inhaled corticosteroids (ICS), long-acting beta agonists, and
long-acting muscarinic antagonists. Double maintenance therapy was
allowed if ICS was contraindicated.
The primary endpoint evaluated the annualized rate
of acute moderate or severe COPD exacerbations. Moderate
exacerbations were defined as those requiring systemic steroids
and/or antibiotics. Severe exacerbations were defined as those:
requiring hospitalization; more than a day of observation in an
emergency department or urgent care facility; or resulting in
death. Key secondary endpoints included change from baseline in
lung function (assessed by pre-bronchodilator FEV1) at 12 and 52
weeks; change from baseline at week 52 in SGRQ total score compared
to placebo; proportion of patients with SGRQ improvement ≥4 points
at week 52; and the change from baseline at 52 weeks in the ERS:
COPD Scale symptom scoreThe second, replicate Phase 3 trial of
Dupixent in COPD (NOTUS) is ongoing with data expected in 2024.
About Sanofi and Regeneron’s
COPD Clinical Research ProgramSanofi and Regeneron
are motivated to transform the treatment paradigm of COPD by
examining the role different types of inflammation play in the
disease progression through the investigation of two potentially
first-in-class biologics, Dupixent and itepekimab. Dupixent
inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) pathways and the program focuses on a
specific population of people with evidence of type 2 inflammation.
Itepekimab is a fully human monoclonal antibody that binds to and
inhibits interleukin-33 (IL-33), an initiator and amplifier of
broad inflammation in COPD. Across both programs, four Phase 3
trials are ongoing and designed to inform next-generation
treatments for people with COPD whom might not have other
options.
About DupixentDupixent is a fully
human monoclonal antibody that inhibits the signaling of the
interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not
an immunosuppressant. The Dupixent development program has shown
significant clinical benefit and a decrease in type 2 inflammation
in Phase 3 trials, establishing that IL-4 and IL-13 are key and
central drivers of the type 2 inflammation that plays a major role
in multiple related and often co-morbid diseases. These diseases
include approved indications for Dupixent, such as atopic
dermatitis, asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP), prurigo nodularis and eosinophilic esophagitis (EoE).
Dupixent has received regulatory approvals in one
or more countries around the world for use in certain patients with
atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in
different age populations. Dupixent is currently approved for one
or more of these indications in more than 60 countries, including
in Europe, the U.S. and Japan. More than 600,000 patients are being
treated with Dupixent globally.
Dupilumab Development
ProgramDupilumab is being jointly developed by Sanofi and
Regeneron under a global collaboration agreement. To date,
dupilumab has been studied across more than 60 clinical trials
involving more than 10,000 patients with various chronic diseases
driven in part by type 2 inflammation.
In addition to the currently approved indications,
Sanofi and Regeneron are studying dupilumab in a broad range of
diseases driven by type 2 inflammation or other allergic processes
in Phase 3 trials, including pediatric EoE, hand and foot atopic
dermatitis, chronic inducible urticaria-cold, chronic spontaneous
urticaria, chronic pruritus of unknown origin, COPD with evidence
of type 2 inflammation, chronic rhinosinusitis without nasal
polyposis, allergic fungal rhinosinusitis, allergic
bronchopulmonary aspergillosis and bullous pemphigoid. These
potential uses of dupilumab are currently under clinical
investigation, and the safety and efficacy in these conditions have
not been fully evaluated by any regulatory authority.
...About RegeneronRegeneron (NASDAQ: REGN) is a
leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for 35 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to nine FDA-approved treatments and numerous
product candidates in development, almost all of which were
homegrown in our laboratories. Our medicines and pipeline are
designed to help patients with eye diseases, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic
diseases, pain, hematologic conditions, infectious diseases and
rare diseases.Regeneron is accelerating and improving the
traditional drug development process through our proprietary
VelociSuite® technologies, such as VelocImmune®, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.For more information, please visit www.Regeneron.com or
follow @Regeneron on Twitter.
About SanofiWe are an innovative global healthcare
company, driven by one purpose: we chase the miracles of science to
improve people’s lives. Our team, across some 100 countries, is
dedicated to transforming the practice of medicine by working to
turn the impossible into the possible. We provide potentially
life-changing treatment options and life-saving vaccine protection
to millions of people globally, while putting sustainability and
social responsibility at the center of our ambitions. Sanofi is
listed on EURONEXT: SAN and NASDAQ: SNY.
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